FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90049–90072 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1998
SILICONE PUNCTAL PLUG
K980437 · LZU
Oasis Medical, Inc.
Ophthalmic · 85d
Cleared Apr 30, 1998
SPIROMETER MODEL NPB-500
K980441 · BZG
Nellcor Puritan Bennett, Inc.
Anesthesiology · 85d
Cleared Apr 30, 1998
PEAK FLOW METER MINIMAX
K980443 · BZH
The D&T, Inc.
Anesthesiology · 84d
Cleared Apr 30, 1998
MENTOR SUSPEND SLING
K980483 · FTL
Mentor Corp.
General & Plastic Surgery · 80d
Cleared Apr 30, 1998
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
K980534 · KRH
The Heart Valve Div. Medtronic...
Cardiovascular · 78d
Cleared Apr 30, 1998
JUMBO GLASS IONOMER CEMENT
K980568 · EMA
Centrix, Inc.
Dental · 80d
Cleared Apr 30, 1998
PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)
K980616 · EBI
Kohler Medizintechnik GmbH & Co. KG
Dental · 71d
Cleared Apr 30, 1998
N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE
K980623 · GCJ
N-Tech Endoscopy, Inc.
General & Plastic Surgery · 72d
Cleared Apr 30, 1998
PROTEC CEM.
K980922 · EMA
Ivoclar North America, Inc.
Dental · 50d
Cleared Apr 30, 1998
KLEENASEPTIC
K981023 · LRJ
Metrex Research Corp.
General Hospital · 42d
Cleared Apr 30, 1998
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY...
K981280 · IXW
Bayer Corp., Agfa Div.
Radiology · 22d
Cleared Apr 29, 1998
CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM
K974674 · GEX
Cynosure, Inc.
General & Plastic Surgery · 135d
Cleared Apr 29, 1998
SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
K980360 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Apr 29, 1998
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
K980364 · HWC
Howmedica Corp.
Orthopedic · 90d
Cleared Apr 29, 1998
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
K980373 · HCC
Ultramind International , Ltd.
Neurology · 89d
Cleared Apr 29, 1998
INNOVASIVE LINX TIBIAL LIGAMENT FASTENER
K980491 · MBI
Innovasive Devices, Inc.
Orthopedic · 79d
Cleared Apr 29, 1998
THE NUFFIELD TOTAL KNEE SYSTEM
K980545 · JWH
Corin USA
Orthopedic · 76d
Cleared Apr 29, 1998
INNOVASIVE DEVICES MENISCAL SCREW
K980681 · HWC
Innovasive Devices, Inc.
Orthopedic · 68d
Cleared Apr 29, 1998
OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS
K980774 · LZO
Osteonics Corp.
Orthopedic · 58d
Cleared Apr 29, 1998
ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
K980776 · JXM
Tcpi, Inc.
Toxicology · 58d
Cleared Apr 29, 1998
SURETOUCH
K980784 · GEX
Sahar Technologies, Inc.
General & Plastic Surgery · 58d
Cleared Apr 29, 1998
DUMEX PAK-ITS WOVEN RIBBON PACKING
K980791 · EFQ
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 58d
Cleared Apr 29, 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · JLW
Abbott Laboratories
Chemistry · 37d
Cleared Apr 29, 1998
BRIGHTSTAR
K981081 · FSY
Hill-Rom, Inc.
General & Plastic Surgery · 36d